Fractionated Boron Neutron Capture Therapy in Locally Recurrent Head and Neck Cancer : A Prospective Phase I/II Trial
Copyright © 2016 Elsevier Inc. All rights reserved..
PURPOSE: To investigate the efficacy and safety of fractionated boron neutron capture therapy (BNCT) for recurrent head and neck (H&N) cancer after photon radiation therapy.
METHODS AND MATERIALS: In this prospective phase 1/2 trial, 2-fraction BNCT with intravenous L-boronophenylalanine (L-BPA, 400 mg/kg) was administered at a 28-day interval. Before each fraction, fluorine-18-labeled-BPA-positron emission tomography was conducted to determine the tumor/normal tissue ratio of an individual tumor. The prescription dose (D80) of 20 Gy-Eq per fraction was selected to cover 80% of the gross tumor volume by using a dose volume histogram, while minimizing the volume of oral mucosa receiving >10 Gy-Eq. Tumor responses and adverse effects were assessed using the Response Evaluation Criteria in Solid Tumors v1.1 and the Common Terminology Criteria for Adverse Events v3.0, respectively.
RESULTS: Seventeen patients with a previous cumulative radiation dose of 63-165 Gy were enrolled. All but 2 participants received 2 fractions of BNCT. The median tumor/normal tissue ratio was 3.4 for the first fraction and 2.5 for the second, whereas the median D80 for the first and second fraction was 19.8 and 14.6 Gy-Eq, respectively. After a median follow-up period of 19.7 months (range, 5.2-52 mo), 6 participants exhibited a complete response and 6 exhibited a partial response. Regarding acute toxicity, 5 participants showed grade 3 mucositis and 1 participant showed grade 4 laryngeal edema and carotid hemorrhage. Regarding late toxicity, 2 participants exhibited grade 3 cranial neuropathy. Four of six participants (67%) receiving total D80 > 40 Gy-Eq had a complete response. Two-year overall survival was 47%. Two-year locoregional control was 28%.
CONCLUSIONS: Our results suggested that 2-fraction BNCT with adaptive dose prescription was effective and safe in locally recurrent H&N cancer. Modifications to our protocol may yield more satisfactory results in the future.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2016 |
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| Erschienen: |
2016 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:95 |
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| Enthalten in: |
International journal of radiation oncology, biology, physics - 95(2016), 1 vom: 01. Mai, Seite 396-403 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Wang, Ling-Wei [VerfasserIn] |
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| Links: |
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| Themen: |
47E5O17Y3R |
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| Anmerkungen: |
Date Completed 25.08.2016 Date Revised 16.02.2020 published: Print-Electronic Citation Status MEDLINE |
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| doi: |
10.1016/j.ijrobp.2016.02.028 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM259461571 |
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| 100 | 1 | |a Wang, Ling-Wei |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Fractionated Boron Neutron Capture Therapy in Locally Recurrent Head and Neck Cancer |b A Prospective Phase I/II Trial |
| 264 | 1 | |c 2016 | |
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| 500 | |a Date Completed 25.08.2016 | ||
| 500 | |a Date Revised 16.02.2020 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a Copyright © 2016 Elsevier Inc. All rights reserved. | ||
| 520 | |a PURPOSE: To investigate the efficacy and safety of fractionated boron neutron capture therapy (BNCT) for recurrent head and neck (H&N) cancer after photon radiation therapy | ||
| 520 | |a METHODS AND MATERIALS: In this prospective phase 1/2 trial, 2-fraction BNCT with intravenous L-boronophenylalanine (L-BPA, 400 mg/kg) was administered at a 28-day interval. Before each fraction, fluorine-18-labeled-BPA-positron emission tomography was conducted to determine the tumor/normal tissue ratio of an individual tumor. The prescription dose (D80) of 20 Gy-Eq per fraction was selected to cover 80% of the gross tumor volume by using a dose volume histogram, while minimizing the volume of oral mucosa receiving >10 Gy-Eq. Tumor responses and adverse effects were assessed using the Response Evaluation Criteria in Solid Tumors v1.1 and the Common Terminology Criteria for Adverse Events v3.0, respectively | ||
| 520 | |a RESULTS: Seventeen patients with a previous cumulative radiation dose of 63-165 Gy were enrolled. All but 2 participants received 2 fractions of BNCT. The median tumor/normal tissue ratio was 3.4 for the first fraction and 2.5 for the second, whereas the median D80 for the first and second fraction was 19.8 and 14.6 Gy-Eq, respectively. After a median follow-up period of 19.7 months (range, 5.2-52 mo), 6 participants exhibited a complete response and 6 exhibited a partial response. Regarding acute toxicity, 5 participants showed grade 3 mucositis and 1 participant showed grade 4 laryngeal edema and carotid hemorrhage. Regarding late toxicity, 2 participants exhibited grade 3 cranial neuropathy. Four of six participants (67%) receiving total D80 > 40 Gy-Eq had a complete response. Two-year overall survival was 47%. Two-year locoregional control was 28% | ||
| 520 | |a CONCLUSIONS: Our results suggested that 2-fraction BNCT with adaptive dose prescription was effective and safe in locally recurrent H&N cancer. Modifications to our protocol may yield more satisfactory results in the future | ||
| 650 | 4 | |a Clinical Trial, Phase I | |
| 650 | 4 | |a Clinical Trial, Phase II | |
| 650 | 4 | |a Journal Article | |
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| 700 | 1 | |a Hsueh Liu, Yen-Wan |e verfasserin |4 aut | |
| 700 | 1 | |a Chou, Fong-In |e verfasserin |4 aut | |
| 700 | 1 | |a Liu, Yuan-Hao |e verfasserin |4 aut | |
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| 700 | 1 | |a Liu, Ching-Sheng |e verfasserin |4 aut | |
| 700 | 1 | |a Lin, Ko-Han |e verfasserin |4 aut | |
| 700 | 1 | |a Wang, Shyh-Jen |e verfasserin |4 aut | |
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| 700 | 1 | |a Lo, Wen-Liang |e verfasserin |4 aut | |
| 700 | 1 | |a Kao, Shou-Yen |e verfasserin |4 aut | |
| 700 | 1 | |a Yen, Sang-Hue |e verfasserin |4 aut | |
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